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ISSCR Comments Before FDA Panel on Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products

13 September, 2016

The International Society for Stem Cell Research (ISSCR) today underscored the need for careful oversight and regulation of stem cell research at every stage in the process of developing therapeutic products for patient use. The comments were presented at a U.S. Food and Drug Administration (FDA) panel on Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products.

“It is imperative that stem cell products be proven safe and effective before they are marketed to patients, and the FDA plays a critical role in this process,” said ISSCR President Sally Temple. “The agency’s guidance should help ensure the public that medicines are safe and effective, and that they have undergone rigorous testing in carefully-designed clinical trials before they are made available for use,” she said.

The ISSCR comments cited its 2016 Guidelines for Stem Cell Research and Clinical Translation that demand robust standards for preclinical and clinical research, as well as independent review and oversight as potential treatments move through clinical testing toward the market. The guidelines focus considerable attention on the preclinical and clinical phases of research, calling for persuasive evidence of clinical promise before clinical trials go forward, and demanding that trials be carefully designed and reported, and independently reviewed.

“The ISSCR guidelines hold that patient welfare is primary,” said Temple. “We are pleased that the FDA is reviewing how best to regulate these treatments, particularly in light of evidence that stem cell products are being advertised and sold directly to the U.S. public before they have been approved for medical use,” she said. Temple noted that the ISSCR is concerned about reports of patients using unproven medical therapies without sufficient information about their safety and efficacy, and the risks involved.

The ISSCR opposes changing the FDA oversight process in ways that would short-circuit the review of stem cell products, noting that thorough independent evaluation and accurate reporting of results helps inform physicians and the public about the potential benefits and risks of stem cell trials and treatments.